Patient Function/Fitness and Psychosocial Health in Improving Health-Related Quality of Life in Patients With Stage I-IV Non-Small Cell Lung Cancer
A Pilot Study Investigating Patient Function/Fitness and Psychosocial Health in Patients With Non-Small Cell Lung Cancer
3 other identifiers
observational
N/A
1 country
1
Brief Summary
This pilot trial studies patient function/fitness and psychosocial health in improving health-related quality of life and decreasing treatment-related toxicity in patients with stage I-IV non-small cell lung cancer. Studying function/fitness and psychosocial health may help doctors improve conventional therapy in patients with non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedFirst Posted
Study publicly available on registry
July 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJuly 27, 2018
July 1, 2018
1 year
May 12, 2016
July 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Patient function/fitness
Assessed by standard health measurements.
Up to 6 months
Patient well-being
Assessed by questionnaires.
Up to 6 months
Patient function/fitness
Assessed by performance-based measures.
Up to 6 months
Patient well-being
Assessed by psychosocial health questions.
Up to 6 months
Study Arms (1)
Ancillary-Correlative (HRQOL, fitness and psychosocial health)
Patients scheduled for surgery, radiation therapy, or chemotherapy complete the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-core 30 (C30) and QLQ-Lung Cancer 13 (LC13) in addition to psychosocial health and smoking status questions from baseline up to 2 weeks prior to the start of treatment, 5-6 weeks after treatment begins, and 5-6 months from the start of treatment. During the same time points, patients also undergo function/fitness assessments including standard health measurements, short physical performance battery (SPPB), 6 minute walk test (6MWT), and a grip strength test.
Interventions
Undergo function/fitness assessment
Undergo psychosocial health assessments
Complete EORTC QLQ-C30 and QLQ-LC13 questionnaires
Eligibility Criteria
Patients with Non-Small Cell Lung Cancer
You may qualify if:
- Newly diagnosed lung cancer
You may not qualify if:
- Previous or active lung cancer treatment at the time of registration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Lally
Wake Forest University Health Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2016
First Posted
July 15, 2016
Study Start
July 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2018
Last Updated
July 27, 2018
Record last verified: 2018-07